Sex in the Laboratory: NIH expectations for gender representation in human and animal research

Sex in the Laboratory: NIH expectations for gender representation in human and animal research

A recent notice from the NIH will likely change how human subject research is planned, reviewed, and conducted.  Although women now account for roughly half of all participants in NIH-supported clinical research, basic and preclinical biomedical research has focused on male animals and cells. NIH expects that sex as a biological variable will be factored into research designs, analyses, and reporting in vertebrate animal and human studies.  Strong justification from the scientific literature, preliminary data, or other relevant considerations must be provided for applications proposing to study only one sex.